FDA Patient Safety News: Show #24, February 2004

Botulism IGIV Approved for Infants

FDA recently approved the first drug to treat botulism in infants under one year of age. The new product is Botulism Immune Globulin Intravenous (Human), and will be sold under the trade name, BabyBIG. It can be used for both type A and type B botulism.

In clinical studies, when BabyBIG was given within the first 3 days of hospitalization, it significantly reduced the length of hospital stay in infected infants. It also reduced the average length of stay in the ICU and the average length of time on a ventilator. Keep in mind, though, that BabyBIG has only been studied in infants under one year of age, so it's not known if the drug would be safe and effective for other age groups.

It's important to remember that IGIV products of this kind may be associated with renal dysfunction, acute renal failure, osmotic nephrosis and death. IGIVs that contain sucrose as a stabilizer, such as BabyBIG, have accounted for a disproportionate number of these events. These events are rare, and no cases of renal failure were seen during the trials. Still, patients predisposed to acute renal failure should receive BabyBIG at the minimum concentration available, and at the minimum rate of infusion feasible. These patients include those with any degree of pre-existing renal insufficiency, diabetes, volume depletion, sepsis or paraproteinemia, and also those on drugs that are known to be nephrotoxic.

Additional Information:

Product Approval Information – Licensing Action.
http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM117160.pdf


Updated Safety Information for ARAVA (leflunomide)

Aventis Pharmaceuticals has sent a letter to healthcare professionals alerting them to new warnings and precautions in the labeling for ARAVA (leflunomide), a drug used to treat active rheumatoid arthritis. The new labeling information is based on reports of rare but serious hepatic injuries, some of them fatal, as well as reports of severe infections, including sepsis. Most of the liver injuries were in patients who had preexisting liver disease or were exposed to other hepatotoxins, and most of the serious infections occurred in patients who had comorbid illnesses or who were receiving immunosuppresants.

The new labeling provides further guidance about liver function tests and adjusting the dose or discontinuing the drug based on these tests. The labeling also provides a schedule of periodic blood tests these patients should receive in order to monitor for possible bone marrow suppression.

If you prescribe ARAVA or care for patients on this drug, you should read the letter from Aventis, which describes in detail the periodic lab tests that should be performed on these patients.

Additional Information:

MedWatch Safety Alert - ARAVA (leflunomide).
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153278.htm


Recall of Certain ComfortGel® Nasal Masks

Respironics, Inc. is recalling some of the company's ComfortGel® nasal masks. The masks are used with CPAP devices to treat patients with obstructive sleep apnea or respiratory failure. The recalled masks were distributed from September 5 through September 15, 2003. The affected devices are being recalled because a small number of these masks don't have a built-in port that allows exhaled air to exhaust properly. Without the port, a patient is likely to re-breathe CO2, leading to a possible oxygen deficiency. In some cases, it's possible that the patient could suffocate. Also, the user instructions with these recalled masks can be confusing, because they tell the patient that the mask does have an exhalation port and doesn't need a separate one. And of course with some of these masks, that's not the case.

At this point, most of these devices been returned to the company, and no patient injuries have been reported. But there could be some patients out there who are still using these masks. If you have a patient who might be using one, you should contact Respironics at 1-800-345-6443.

Additional Information:

Medical Device Recalls. Class 1 Recall: ComfortGel® Nasal Mask.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm064850.htm


Dosing Errors with Roxanol Morphine Sulfate Oral Solution

Elan Pharmaceuticals, the manufacturer of Roxanol morphine sulfate products, has sent a letter to healthcare professionals warning about accidental overdoses of morphine sulfate oral solutions.

They note that Roxanol Concentrated Oral Solution contains 20 mg of morphine sulfate per mL. Serious overdoses have occurred when the medication was prescribed in mg, but then administered in mL. In one case, for example, 5 mg of morphine was ordered, but 5 mL of the Roxanol solution was administered to the patient. So the patient received 100 mg -- a 20-fold overdose.

To prevent such errors, Elan Pharmaceuticals recommends that prescriptions for morphine sulfate oral solution show the concentration of the oral solution to be used, the intended dose of morphine in mg, and the volume of that dose in mL.

For example, if the prescriber wants the patient to have a dose of 15 mg of morphine, here's the way the prescription should be written:

Roxanol 20 mg/mL

Sig: 15 mg (0.75 mL or cc) q 4 hours prn

Dispense: 30 mL

Additional Information:

MedWatch Safety Alert - Roxanol (morphine sulfate) Concentrated Oral Solution.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm153486.htm


Caution on Rapid Administration of IV Push Medications

The Institute for Safe Medication Practices recently warned about potentially harmful errors that can occur when IV medications are administered too quickly.

ISMP cites several examples of these kinds of errors. Sometimes they've been minor, like the rapid administration of IV ampicillin. Other cases have been more serious. For example, severe hypotension and Red Neck Syndrome (flushing of the upper body) can occur when IV vancomycin is given too rapidly. Serious adverse effects can also occur with too-rapid administration of potassium chloride. The same holds true for VERSED (midazolam), which should be given slowly while the drug's effects on the patient are monitored.

ISMP also reports on a case that led to a patient's death. An ED physician prescribed a labetalol 20 mg IV push for a patient experiencing a hypertensive crisis. The nurse got the drug quickly, but the patient was already being transported to radiology. So on the way, the nurse administered the drug in a matter of seconds. The patient immediately arrested and could not be resuscitated.

Here are some of ISMP's recommendations to reduce patient harm from rapid injections of IV medications.

First, for medications that have a high risk of adverse events when given too fast, provide practitioners with ready access to information about the maximum rate of administration, in mg per minute. Provide this information as an alert on pharmacy-applied product labels and as a special notation on computer-generated medication administration records. Also, post a list of these drugs and their administration guidelines in medication use areas, or on a hospital intranet, or in a small pocket guide.

Second, consider using less concentrated solutions when you're giving a drug that could be dangerous if administered too quickly. For example, you could use the 1 mg/mL strength of VERSED, rather than the 5 mg/mL strength, so staff can titrate the dose slowly during administration. Or you could dilute medications and administer them as a piggyback or with an infusion pump. And you could use a syringe pump to infuse small volume IV medications.

Finally, with drugs that should be administered for one minute or longer, avoid using terms such as "IV push", "IVP", or "bolus." Use more specific terms, like "IV over 5 minutes".

Additional Information:

ISMP Medication Safety Alert. "How fast is too fast for IV push medications?" May 15, 2003.
http://www.ismp.org/MSAarticles/how.htm


Fatal Errors in Administering Intrathecal Contrast Media

Here's a story you may want to pass on to colleagues in the radiology department. The Institute for Safe Medication Practices recently reported on a patient who received an intrathecal injection of the wrong contrast medium prior to undergoing myelography and died as a result.

ISMP points out that only certain products can be safely used intrathecally. In fact, FDA requires the manufacturers of contrast media that are not intended for this use to mark the packages "not for intrathecal use" or "not for myelography."

But these warnings can still be overlooked, and so ISMP has several suggestions to minimize the possibility of error. For example, the pharmacy might consider placing auxiliary warning labels on media that should not be used for myelography.

Various types of contrast media could be stored separately, based on their use. ISMP mentions one facility where media for myelograms are stored in a locked box in an exam room that's used exclusively for intrathecal procedures. No other contrast medium is stored there. Another hospital packages special myelogram kits that include the proper contrast medium. Of course pharmacists should visit these areas periodically to be sure that the right media are in the right places.

And when a contrast medium is to be administered intrathecally, clinical staff should perform an independent double check to be sure the product they're using is the right one for that purpose.

It's also important for the clinical staff to be able to promptly recognize an error and begin treatment, because this may prevent a fatal outcome.

Additional Information:

ISMP Medication Safety Alert. November 27, 2003. "Intrathecal injection of ionic contrast media may be fatal".
http://www.ismp.org/MSAarticles/fatal.htm



FDA Patient Safety News is available at www.fda.gov/psn